Merck Discontinues Vibostolimab And Pembrolizumab Coformulation Arm Of Phase 3 Trial In Melanoma

(RTTNews) - Merck & Co., Inc. (MRK) announced Monday the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial in patients with resected high-risk melanoma.

The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA), Merck's anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant treatment for patients with resected high-risk melanoma or Stage IIB-IV.

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells.

The data, at a pre-planned analysis, showed that the primary endpoint of recurrence-free survival or RFS met the pre-specified futility criteria.

Meanwhile, a higher rate of discontinuation of all adjuvant therapy by patients in the coformulation arm versus the KEYTRUDA-only arm, primarily due to immune-mediated adverse experiences, rendered it highly unlikely that the trial could achieve a statistically significant improvement in RFS.

Based on the recommendation of an independent Data Monitoring Committee or DMC, Merck is unblinding the study and recommends that patients receiving the vibostolimab and pembrolizumab coformulation be offered the option to be treated with KEYTRUDA monotherapy.

Merck noted that data analysis from the study is ongoing, and that it plans to share the results with the scientific community and communicated to regulatory agencies,

In the U.S., KEYTRUDA has two approved indications in melanoma: for the treatment of patients with unresectable or metastatic melanoma, and for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.

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